Medical College of Wisconsin
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Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial. Contemp Clin Trials 2012 Mar;33(2):291-7

Date

12/14/2011

Pubmed ID

22155024

Pubmed Central ID

PMC3577351

DOI

10.1016/j.cct.2011.11.018

Scopus ID

2-s2.0-84856218422   47 Citations

Abstract

BACKGROUND: The NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators.

METHODS: Participating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites.

RESULTS: From December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported.

CONCLUSION: We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.

Author List

Peters-Lawrence MH, Bell MC, Hsu LL, Osunkwo I, Seaman P, Blackwood M, Guillaume E, Bellevue R, Krishnamurti L, Smith WR, Dampier CD, Minniti CP, Sickle Cell Disease Clinical Research Network (SCDCRN)

Author

Deepak Kilari MD Associate Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Acute Pain
Adolescent
Adult
Analgesia, Patient-Controlled
Anemia, Sickle Cell
Attitude of Health Personnel
Child
Clinical Protocols
Female
Follow-Up Studies
Humans
Male
Patient Selection
Retrospective Studies
Surveys and Questionnaires
Treatment Outcome
Young Adult